Gas Supply Line (8 M)
Catalogue number FPRCH6108, listed by Galil Medical Ltd., Israel, under Unit, Cryosurgical, Accessories. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
29510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Galil Medical Ltd., Israel |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| Record published | 2016-08-15 |
| Record revised | 2022-04-08 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store in Visual-ICE Cryoablation System Storage Compartment |
| Sizes | Length 8 m |
| Distribution end date | 2017-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FPRCH6108 | Length 8 m | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203032 | 2020-11-02 |
| K181741 | 2018-07-30 |
| K181153 | 2018-05-15 |
| K173037 | 2017-11-21 |
| K162599 | 2016-10-11 |
| K152133 | 2015-08-28 |
| K143564 | 2015-03-05 |
| K141485 | 2014-07-02 |
| K140584 | 2014-03-31 |
| K123865 | 2013-02-06 |
| K121251 | 2012-08-28 |
| K113860 | 2012-03-12 |
| K111859 | 2011-10-07 |
| K110946 | 2011-06-21 |
| K070482 | 2007-03-20 |
| K060390 | 2006-04-27 |
| K060144 | 2006-02-13 |
| K052530 | 2005-11-18 |
| K051052 | 2005-05-06 |
| K042667 | 2004-10-14 |
| K031117 | 2003-05-23 |
| K021261 | 2002-07-03 |
| K011950 | 2002-01-29 |
| K012497 | 2001-10-30 |
| K010991 | 2001-05-03 |
| K003065 | 2000-10-31 |
| K993965 | 2000-02-18 |
| K991517 | 1999-07-27 |
| K991272 | 1999-07-12 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-25 | Class II | Environmental control | Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance. | 49 systems | 2020-09-16 |
| 2012-07-20 | Class II | Device Design | Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable. | 4 | 2012-09-13 |
| 2012-04-12 | Not classified | Material/Component Contamination | Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders. | 26 kits | 2012-08-16 |
| 2010-12-20 | Not classified | Device Design | This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and | 63 | 2012-03-27 |
| 2010-12-20 | Not classified | Device Design | This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and | 22 | 2012-03-27 |
| 2010-11-11 | Not classified | Other | This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be id | 4 | 2011-12-10 |
| 2007-12-11 | Not classified | Process control | The warming catheter was manufactured with the inlet and outlet tubes switched. | 541 catheters | 2008-09-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.